Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 125019
Company: SPECTRUM PHARMS
Company: SPECTRUM PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ZEVALIN | IBRITUMOMAB TIUXETAN | 3.2MG/2ML | INJECTABLE; INJECTION | Prescription | None | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
02/19/2002 | ORIG-1 | Approval | N/A; Orphan |
Label (PDF)
Letter Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/ibriide021902LB.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/ibriide021902L.htm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/125019_0000_ZevalinTOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/11/2018 | SUPPL-227 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125019s227lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125019Orig1s227ltr.pdf | |
08/30/2013 | SUPPL-213 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125019s210s213lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125019Orig1s210,s213ltr.pdf | |
08/30/2013 | SUPPL-210 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125019s210s213lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125019Orig1s210,s213ltr.pdf | |
11/18/2011 | SUPPL-194 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125019s0194lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125019s0194ltr.pdf | |
12/16/2010 | SUPPL-185 | Supplement |
Label is not available on this site. |
||
09/03/2009 | SUPPL-156 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125019s0156.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125019s0156ltr.pdf | |
03/25/2008 | SUPPL-135 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125019s135lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125019s0135ltr.pdf | |
11/02/2007 | SUPPL-132 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125019s132lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125019s132ltr.pdf | |
01/04/2007 | SUPPL-117 | Supplement |
Label is not available on this site. |
||
09/13/2005 | SUPPL-92 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125019_0092lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125019_0092ltr.pdf | |
07/27/2005 | SUPPL-88 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125019_0088lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125019_0088ltr.pdf | |
10/29/2004 | SUPPL-70 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125019_0070lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/125019_0070ltr.pdf | |
10/22/2004 | SUPPL-58 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125019_0058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/125019_0058ltr.pdf | |
01/30/2003 | SUPPL-8 | Supplement |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/11/2018 | SUPPL-227 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125019s227lbl.pdf | |
08/30/2013 | SUPPL-213 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125019s210s213lbl.pdf | |
08/30/2013 | SUPPL-210 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125019s210s213lbl.pdf | |
11/18/2011 | SUPPL-194 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125019s0194lbl.pdf | |
09/03/2009 | SUPPL-156 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125019s0156.pdf | |
03/25/2008 | SUPPL-135 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125019s135lbl.pdf | |
11/02/2007 | SUPPL-132 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125019s132lbl.pdf | |
09/13/2005 | SUPPL-92 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125019_0092lbl.pdf | |
07/27/2005 | SUPPL-88 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125019_0088lbl.pdf | |
10/29/2004 | SUPPL-70 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125019_0070lbl.pdf | |
10/22/2004 | SUPPL-58 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125019_0058lbl.pdf | |
02/19/2002 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/ibriide021902LB.pdf |